Several questions about settings and behavior of new Biotronik Edora 6 DR-T

Hi everyone, my first post!  I had a Biotronik Edora 6 DR-T implanted about a week ago for sick sinus syndrome, and would appreciate any information or advice on the following.

*    Can this device be causing PVCs or possibly bouts of tachycardia? Or may I be mistaking the PM's activities for these? Over the first few days, I had a lot of what felt like PVCs, sometimes for runs of 5-15 beats, though this calmed down in the next few days. I've had PVCs before (Dr. said not dangerous), but it was never anywhere near this number or frequency. Does the PM detect, prevent, or otherwise affect PVCs? The reason I doubt it's the PM directly is that these runs tend to start suddently (and without any obvious reason), and stop just as abruptly. 

*     Is the rate adjusting algorithim a bit trigger happy? Tracking my heart rate over nights, I can see that it's 55 BPM when resting VERY QUIETLY in bed (min rate set to 55), but any movement or sitting up will jump it to 75 BPM very quickly, and if I get up for a bathroom break it will quickly go to 90BPM. (FYI CLS - Closed Loop Stimulation - is turned on.)

*    What's a normal decay rate once the PM ups the BPM? It seems to take 3-5 minutes for it to settle back down to the 55-60 BPM range after spiking to 90 or so when I get up and move around. My "old" heart would return to my natural base rate (35-40 BPM) much quicker, but perhaps that's not normal.

*     Despite all this, when exercising (stationary bike) I can only get my heart rate up to about 115 BPM max, which is about the same as before the PM. My max rate is supposedly set to 130 BPM, but I can't seem to figure out how to get it there. Do I need to try some other form of exercise that will cause the accelerometer to trigger more? Jumping jacks? ;)

*    The "CardioMessenger Smart" monitoring device supposedly transmits a daily report to ... someone somewhere. It's not plausible that my cardiologist at Kaiser Northern CA reads daily reports from all his patients. Practically speaking, how is this handled?

*     Do the reports include any measures of unusual events, such as excessive PVCs or tachachardia? Will it flag any arrythmia problems, like those noted above?

*     Is it possible for a patient (me) to get copied on the reports, or is this a "professionals only" thing?

*     This may be a conicidence or my imagination, but around 2AM every night I get woken up by some unusual heart activity, I suspect the PM may be doing some nightly testing? If so, can I get this reduced in frequency to say once a week, and perhaps moved to 8AM when it would be less disruptive (and I can anticipate it)?

*     Since the PM can be set for both day and night rates, it stands to reason that it contains a clock. (Mine is set to a min rate of 55 BPM for both day and night.)  Digital clocks tend to drift, though most "internet connected" devices will read the time and reset themselves periodically. Is the PM clock adjusted nightly when talking to the CardioMessenger Smart, only when programmed, or never? What happens when I travel to a distant time zone, does this adjust in any way?

*     I've read a lot of conflicting info about interference, mainly from magnets and EMI. My PM is supposed to be MRI safe, but what's the "failure mode" in these cases, i.e. does the PM stop working temporarily, revert to the minimum BPM, etc.?

Thanks for any help or advice!


7 Comments

So many questions...

by AgentX86 - 2021-10-07 00:17:13

First, welcome to the club.  We wish you weren't here. There are worse places to hang out though.

Can your device be causing PVCs?  I guess that depends on your definition of "causing".  A week after implant it's not uncommon for the heart to still be pissed off.  It can take a while for the heart to used to pacing.  Cause?  Not in my definition.  Common just after implant? Certainly.  Your EP can have your pacemaker set up to record strings of PVCs.  Mine can't record single PVCs but strings above five, it can.  PVCs are just too common to record them all.  They would fill memory in short order.

Trigger happy RR?  Yes, that's certainly possible.  I have mine (Medtronic, though) intentionally set way on the sensitive side.  I'd rather have some unwanted heart rate acceleration than not being able to accelerate, if you know what I mean.  Yes, it's normal for it to take a while to spool down again.  That's all programmable.  You can get it set the way you like. CLS has been known to be more of a problem than solution. They turned all that automatic suff off on mine.  You're not to that point yet.  It'll be several weeks  before they're likely to go poking the settings.  If you can stand it at all, they'll probably leave well enough alone until your  heart settles down.  Having it jump for a pee break is normal, if a little odd. Your rate response is set to be very sensitive but they've also set a pretty low maximum rate.  A low maximum rate, for the first month or so, isn't unusual.  Ask your EP about all this stuff.  He should take time to explain anything you're interested enough to know.  Show some interest by researching settings (or whatever) and EPs will tend to spend more time teaching the nuts and bolts.  Most don't want to know, so they're not told - not even what they really should know.

Yes, you can get a copy of all of your PM settings. The are medical records and you have a right to all medical records. Sometimes your device tech will just give you what you want.  Some carry a USB stick with them to get all of the settings.  You can then, with the help of online technical references for your PM, learn more about your pacemaker and what's possible.  Some here direct the device tech precisely how they want their PM set up.  A good device tech will allow some latitude, within the limits set by your EP.  An EP will have to sign off on the settings at some point (EP full employment policy).

No, your edside box cannot make ANY changes to your PM.  Doing so would open a huge security hole you don't want to even think about.  Changes can only be made in the office using the manufacturer's programming tool.

My PM is programmed with a night-time mode.  It paces at 80bpm during the day and 50bpm at night (12:00AM to 6:00AM EST).  I haven't noticed any drifting but I don't check my pulse every second, either.

Don't sweat magnets so much.  Even if you did get a super-magnet too close, your PM would just go into a default mode where it just paces at a known rate with all features turned off.  During an MRI, there will be a device tech to download all of your settings into his programmer, then put the PM into a default mode.  After the MRI he'll just reverse the process.  It only takes a few seconds.  However, for this reason you have to go to a hospital with a cardiac department to get an MRI.  You won't be able to go to one of the cheap MRI-in-a-Box places down the block.  You'll also play hell getting everyone to sign off on all the paperwork for you to get an MRI.  Radiologists are a conservative bunch.  They won't take risks, themselves.  They'll want someone else to be on the hook for any problems.  To be fair, PMs aren't their thing. They want a cardiologist to tell them it's OK.

There are other issues, like high moving magnetic fields (large motors, transformers, welders, etc.) that can be a problem.  These can fake your PM into thinking the heart is pacing itself when it isn't.  It may inhibit (fail to supply the pacing signal).  Other than some large welders, this is highly unlikely.  There are only a few things likely to be found aroung the home that are of any concern at all.  A good life strategy is to ignore lawyers unless you've hired them.

Remote Monitoring

by Marybird - 2021-10-07 12:44:22

Hi Jerry,

Lots of good questions, looks as though Agent's provided lots of good information that could be applied to your situation.

I just wanted to add what I recently learned about the "process" of remote monitoring, ie, goes where, when, who looks at it, ( or as I wondered for some time, does ANYONE really look at it?)

I have a St. Jude dual pacemaker ( Assurity MRI+), implanted in June 2019 for sick sinus syndrome ( tachy-brady here). So the process I learned about is for the Abbott/St. Jude cardiac devices using the "Merlin at Home" monitor/ transmitter with Abbott's "Merlin.PCN" ( whatever, whatever) secure website which stores the transmissions uploaded by zillions of pacemakers/ICDs/implantable monitors everywhere, and makes them accessible to each patient's doctor or pacemaker clinic on demand. But I'm thinking this process, which was explained to me  by the pacermaker clinic technician at my cardiologist's office during a recent in-office device check, is probably pretty much the same regardless of the manufacturer. Basically, your doctor chooses the frequency, types of notifications, and settings for the criteria for notification depending on your condition/diagnosis.

Here's the way mine goes, according to the pacer tech ( I figured it's probably typical): my pacemaker communicates via bluetooth each night with the monitor, usually in the wee hours when it's assumed most people will be sleeping. The monitor uploads that nightly communication but does not transmit unless there is a parameter that excedes the programmed threshhold ( say, tachycardia exceding the threshhold, automatic mode switches, lead problems, etc). The monitor does transmit those reports to the manufacturer's website at intervals programmed by your doctor ( many, including mine, go every 91 days). The pacer tech informed me that the manufacturer doesn't read, review, or interpret those reports, but just makes them available to the doctor or pacer clinic, and whoever in the clinic is responsible for checking these reports does just that. Report showing parameters out of the programmed threshold are flagged depending on their order of urgency, and a responsible contact ( determined by each practice) can be notified ( via email, text, or whatever contact method they choose) directly for parameters that might need urgent or ASAP clinical intervention. The pacer tech told me she gets text messages for those more "urgent reports", and for these and the other reports, she "triages" the information with the patient's medical information, sends it along to the PA and the doctor, who will notify the patient as indicated. This worked for me for several hours' long afib incidents I went through in late May, early June. They told me earlier monitoring reports showed I'd been having short runs of afib ( some apparently setting off excess mode switching alerts) so they increased the metoprolol I was taking for heart rate control, but the longer episodes of afib for which they were alerted earned me a visit to the cardiologist and a prescription for Eliquis.

In any case, the basic (wireless) monitoring process seems to be, 1) pacemaker communicates with monitor ( automatically if it's wireless)- many at nightly intervals, 2) monitor sends reports at intervals programmed by your clinic/doctor to the secure website provided by the manufacturer, 3) reports available and checked by designated personnel in the clinic/practice, reviewed, signed as indicated by doctor. Reports showing abnormal perameters or information that might indicate the need for clinical action are flagged ( I've seen red, yellow stars next to these), and designated personnel may be urgently contacted via text, phone, ( whatever they choose).

I'd imagine that Kaiser would have a large cardiac device clinic where there are a number of pacing techs, nurses, other trained personnel employed that read, review and triage the reports with clinical information for their patients. They'd send the completed report to the doctor, or notify the doctor ASAP in the event of incidents needing clinical action.

Another variation in this monitoring process- one that's currently used by my cardiologist's office, would be the use of an outside monitoring company to review their patients' reports uploaded to the manufacturers' websites. The company ( they tell me they have pacer techs, and some EP's)  makes sense of the pacemaker data, interprets and sends a completed report- downloads it to the patients electronic health records, so it's available to the doctor, or the pacemaker clinic personnel. I'd think such a monitoring company would be used mostly by smaller cardiac practices in lieu of hiring enough in-house technicians to handle the volume of cardiac device patients they have. Or perhaps they'd be used in practices without their own on-staff EPs where they have a smaller volume of cardiac device patients. That's just speculation on my part.

I'd think a healthcare facility as large as Kaiser would have a large enough patient volume that they'd find it more cost-effective to have a large cardiac device clinic that employs a number of their own personnel. But that's a question you could ask of your providers- what your settings are for alert notification, what's their process of monitoring, who does what?

Best of luck, and be well!

Many Thanks to Agentx86 and marybird! ... and of course more questions...

by Jerry10 - 2021-10-07 15:54:15

First of all thank you both so much for the detailed and informative responses. These were VERY helpful for me!

Since I was in bed but awake for several hours last night, I was able to study my PM's performance using (1) my Apple watch as a pulse meter, (2) with earplugs in, actually listening closely to my own heartbeat, and (3) feeling what was going on in my chest - pressure, discomfort, etc.  Here's what I found, but this is of course my interpretation and may not be reality.

At complete rest and motionless, the PM maintained 55 BPM like clockwork, as expected.

I had isolated PVCs, probably 5-10 a minute.

Every 2-3 minutes on average, with high variation, something would happen that felt like sequential PVCs, for periods of 10-20 seconds, then my heartbeat would abruptly return to normal. Subjectively, it felt like my ventricle(s?) was uncoordinated with my atrium. What I heard was a regular atrium "beat" with some random additional actitivity superimposed over it. It was hard to tell for sure, but the superfluous activity didn't seem very regular - it wasn't like 2x, or just time-shifted or anything. In general it was faster than the PM setting of 55.

Now the interesting part: I think the CLS algorithm in my Biotronik PM interpreted this activity as a call for more power - during these episodes it quickly ramped up 20 BPM from 55 to 75, paused there, and then if the episode continued for more than approximately 15 seconds, it ramped up another 20 BPM to 95.

In the course of an hour, laying essentially still in bed, this spiked my BPM from 55 to 75 or 95 perhaps 5-10 times! Often the PM didn't have time to "recover" to the base rate before the pattern started again. 

While I didn't note any physical symptoms (sweating, pain, etc.), this was distracting to say the least, which is probably why I'm getting so little sleep since the implant procedure.

Oddly, I'm NOT seeing the same thing during the day, which I have no explanation for. Maybe because I'm upright??

So if I'm right, my PM is chasing its tail: strings of PVCs are causing it to spike my BPM, which is probably causing some physiological stress that is exacerbating the PVCs.

Does this sound plausible? If I were to turn off the CLS algorithm, and go with simple accelerometer sensing, might this reduce the problem? And why is my venticle going rogue on me?  Would the PM data reports show this?

Thanks again for all the support,

Jerry

 

 

Tail chasing

by AgentX86 - 2021-10-08 00:02:04

I don't believe CLS has anything to do with this.  CLS is their rate response algorithm.  It does sound like there is an algorithm that's trying to surpress your PVCs.  PVCs aren't regular but they tend to come at some rate (with  a random variation).  The heart's electical system works as a first come, first served sort of machine.  Whichever comes first, the natural pace or the artifical pace, wins.  Pacemakers will "inhibit" if a natural pace is seen but the heart won't.  It'll try to pace no matter what.  If the pacemaker fires before the natural pace, the heart is already in motion so the natural pace is ignored by the heart.

The same thing happens in the ventricle.  If the A/V node doesn't cause a beat within a certain time, the pacemaker will substitute its pacing signal.  If the natural pace from the A/V node gets there, but late, it's ignored.  The ventricles have already been triggered.  Reduce the time between paced beats and the natural pacemaker never has a chance to fire.  As an aside, this is why the pacing ratio goes up as the PM's minimum heart rate is raised.  At the higher rate, the pacemaker is beating the SI node to the punch more often.

The same thing happens with PVCs.  If the heart rate is raised some, the chances of a PVC taking over are reduced.  It sounds like this is what's happening to you.  No, it's not chasing its tail, creating more PVCs.  Just the opposite, really.  It's trying to out-pace them, hoping that they'll settle down so the PM can reduce the rate back to normal.

At least I think this is what's happening.  It's only my guess (I don't even know if your PM has this option).  This is a very good question for your EP.  He should be telling you what to expect with any of these algorithms.  Knowledge reduces anxiety. 

AgentX86 - Evidence that you are spot on...

by Jerry10 - 2021-10-08 20:04:19

I went for my first "wound check" yesterday, and discussed this issue, of course. They hooked me up to the PM programmer, and were able to see examples of the problem: My ventricle was firing at mostly random times, sometimes just BEFORE the PM signal to the sinus node; sometime too soon AFTER. 

My min PM rate was 55. They reset it to 65.  FYI my pacing was 90%, but atrium only ... as I understand it the PM didn't detect that I needed any ventricle pacing, since it was firing on its own (even though improperly).  

While it's only been one night, the difference is substantial - virtually no PVCs, etc., which is consistent with your analysis. THANKS!

I'll let this settle in for a few weeks, then at my next appointment (in a month) likely ask them to lower the rate to 60 and see if the problem returns. This is mostly psychological, but 65 feels like I've taken some party drug or something - bam bam bam. ;)

 

On a separate note, lots of people on this forum talk about EPs. I had to look it up - I assume it refers to an electrophysiologist.  I'm a patient at Kaiser Northern CA, and no one has mentioned this term much less have I seen one. I believe the cardiologist I saw (only once before surgery) is a surgeon, not an EP.  He literally scheduled me for surgery instantly based solely on my symptom description, no physical exam, which I found odd, but I had no reason to disagree. (After his recommendation he offerred to give me a stress test "if I wanted one", which I did.)

At my first/only post-op appointment yesterday, the only people present were a young rep from the manufacturer (Biotronik), and a nurse who was clearly in training in how to monkey with the programmer settings.  Didn't inspire a lot of confidence, but at least the rep was able to see the problem in my EKG.  He did disappear to "check with a doctor" before raising me to 65.

Should I be concerned about any of this? I'm not inclined to raise a fuss unless I have unresolved problems or other serious doubts about the level of service.

Thanks,

Jerry

Mutual respect

by Gemita - 2021-10-09 02:25:22

Jerry, I found one of your comments above rather implausible and another quite offensive.

Your statement about your Cardiologist:  “He literally scheduled me for surgery instantly based solely on my symptom description, no physical exam, which I found odd, but I had no reason to disagree ....") sounds implausible to me.  There usually has to be an indication, confirmed by tests before a responsible, qualified doctor would go ahead with pacemaker surgery, at least this has been my experience here in the UK.

Your further statement, which I found offensive to our hard working nursing community, was:  “At my first/only post-op appointment yesterday, the only people present were a young rep from the manufacturer (Biotronik), and a nurse who was clearly in training in how to monkey with the programmer settings.  Didn't inspire a lot of confidence …".  Good nurses and doctors work extremely hard to help their patients.  Nurses certainly do not enter the profession “to monkey around”.  

If you have no faith in those treating you, I would respectfully suggest that you find a team of doctors and nurses that you can work with and please try to show some respect yourself for the medical profession.  Your comments so far do not convince me that you are genuinely looking for support.  We have many caring members in this Club, some of whom have medical, nursing or technical backgrounds and are always reaching out to help.  Potentially offensive remarks have no place on this forum.  

Yes, to answer your question, you should be concerned if you are “genuinely” feeling worried about your well being or have serious doubts about the ability of those treating you.  If this is the case, then you should seek a second opinion as soon as possible with an Electrophysiologist who will have expert knowledge in the electrical system of the heart, who will hopefully confirm your diagnosis and reason for your pacemaker. However to see a 'qualified' manufacturer technician and a trainee member of your pacemaker clinic on your first follow up visit (for essentially a wound check?) would not be that unusual.  I certainly didn't see my doctor on my first follow up at 7 days, although I did at three months.

On the other question of PVCs, mine are always worse at night as my heart rate naturally slows.  That is why we are usually better during the day (when upright) since our heart rate will be higher.  With increased heart rates, as you are experiencng from your changed settings, the PVCs may settle or disappear.

Sincere apology

by Jerry10 - 2021-10-09 17:15:21

Gemita - 

Please accept my apology  - I didn't realize my comments might be interpreted as a slight against my care team, but I can certainly see that is a reasonable conclusion based on what I wrote.  My focus was on the process and relative lack of information, fueled in part by about a week of pain, little sleep, etc. :(

One of the reasons I like Kaiser Northern CA is that the caregivers, with rare exceptions, have been competent, well trained, and very focussed on the patients' well being. This is certainly true of the cardiac unit staff. No disrepect to them. But the process is streamlined for efficiency, not bespoke high-touch patient care - unless you speak up forcefully and are willing to battle your way past automated systems. 

The hospital experience (my first) was outstanding - everything was organized around the patient experience and outcome, and the care team was as coordinated as a sports team. Everyone introduced themselves, explained their role and what they were going to do, and were very responsive to any questions or concerns that I had.

But the reason Kaiser can provide this level of care is their focus on automating processes and being highly efficient. Their challenge, which they largely succeed at, is to do this without sacrificing the level of care.

I'm certainly not a typical patient (which I can see is true of many people on this forum!). Most take the doctors' and staff's word at face value.  I always check it out, particularly if they are recommending something like putting a computer in my chest! I read the manual, found Pacemaker Club (thank God), and did a lot of research. 

By contrast, consider my father-in-law, who will obey without question any medical professional. His doctor (not at Kaiser) sent him to a cardiologist who recommended a PM. He never questioned this or any other aspect of his care. When he was released from the hospital, he never walked again, and has been bedridden since. Why? He was ambulatory before (walk to the kitchen, etc.), with a walker for assistance. But a few days without using his legs, and post op instructions not use his left arm ruled out the walker, he quickly became immobile permanently, which obviated most of the reason for the PM in the first place. IMO this would have been a predictable outcome had he had more "holistic" care sensitive to his particular situation. Indeed my wife predicted this. 

That said, Kaiser is to healthcare what an ATM is to a bank. Most of the transactions you want to do are straightforward, efficient, accurate, and fast. On the rare occasions when you have a problem, you can always go stand in line in a branch.

The automated systems at Kaiser are great - for example the pharmacy nags me if I haven't purchased my meds at the proper frequency. But lately, it can be a bit comical. It has started literally making specific appointments autonomously. Sorry to say this is often driven by what Medicare (here in the US) will reimburse.

Here's how this can go wrong if you don't watch carefully and ask lots of questions:

*   I had a video appointment with my primary care doctor a few months ago, where he though I made the appointment and I thought he did. Neither of us had any idea why we were meeting. The system had generated some sort of automated followup, without explanation. 

*  One day I got an "appointment reminder" to come in for some unspecified blood tests at a specific date and time, with no explanation. I went in, they took the blood, and some seemingly random tests were done. An automated system reported the results to me, all normal. I realized afterwards that no human  other than me was involved in this transaction at all - no one ordered the test, no one interpreted the results. However, it was billable to Medicare.

Now in this latter case, what was I supposed to do? There was no one to contact to ask what this was for or why. The notification came from a do-not-reply address. There was no phone number or department listed. It was easier to just do it than to try to find out what it was about.

So Gemita, sorry for the long message (too much time on my hands recovering!), but the facts remain:

1.    I saw my cardiologist for one visit of about 15 minutes before he scheduled me for surgery. He never physically touched or examined me. He had access to various historical test results, such as an echocardiogram, that were months or years old, ordered for different reasons. He asked my symptoms, listened, then announced that I had a classic presentment, needed a PM, and that was it. (And, he was right.) The next time I saw him, for perhaps 1-2 minutes, was prior to surgery. Post surgery, I have yet to see him again.

2.   I was left to explain my post-op issues to the nurse and the tech, neither of whom were qualified or tasked to deal with them. The nurse's job was to check the wound for problems, the tech's job was to check that the PM was working as expected. The nurse was also in training on how to operate the programmer. Both were fully competent, but there was no evident process for a general welfare check or followup with the patient. In fact, the nurse (being new to PM procedures) expressed surprise that no doctor contact was part of the post-op process, and I agree.

3.   The only information about the procedure was in written form and a short video about "what to expect". That's why I had no idea that the PM could exacerbate my existing benign PVC issues, never heard of an EP, and have relied (thankfully!) on this forum for most of my detailed information.

This said, if I think I have a problem I can email the doctor, which is the "safety valve" for emerging issues at Kaiser. Honestly I think this is fine, but at Kaiser the patient really has to be willing to do research and speak up if their problem is slightly off the beaten path.

Jerry

 

 

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